11
Participants
Start Date
July 17, 2019
Primary Completion Date
May 4, 2022
Study Completion Date
July 19, 2022
INM004
"The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. Each vial contains 25 mg protein/mL. Therefore, each subject must receive 0.16 mL/kg.~The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 24 h between doses."
Placebo
"The IMP dose to be studied will be 4 mg of protein/kg of subject's weight. Each vial contains 25 mg protein/mL. Therefore, each subject must receive 0.16 mL/kg.~The IMP will be added to the 100 mL infusion bag of saline solution. Doses will be administered as an infusion at 2.0 mL/min over 50 min with an interval of 24 h between doses."
Hospital Italiano de Buenos Aires, Ciudad Autonoma de Buenos Aire
Hospital Elizalde, Buenos Aires
Hospital Penna, Bahía Blanca
Hospital Sor Maria Ludovica, La Plata
Hospital Lucio Molas, Santa Rosa
Hospital Castro Rendon, Neuquén
Hospital Orlando Alassia, Santa Fe
Lead Sponsor
Collaborators (1)
Exeltis
INDUSTRY
Inmunova S.A.
OTHER